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All participating patients accepted the device and no application errors or malfunctions were observed.
The majority of malfunctions were observed for disposable pumps; however, programmable pump malfunctions constituted ∼20% of the total malfunctioning pumps.
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The UMBA was set active during the test and no malfunction was observed during the exposure to the proton beam.
No evidence of device malfunction was observed.
No pump or catheter malfunction was observed during the study.
Calcium was initially infused through the return line of the circuit (in the first 8 patients), but an increase of catheter malfunction was observed, so the protocol was changed and calcium infusion was administered through a different central venous line.
Calcium was initially infused through the return line of the circuit (in the first 8 patients), but an increase of catheter malfunction was observed, so the protocol was changed and calcium infusion was administered through a different central venous line (according to some protocols in adult patients [ 5]), after which the incidence of catheter malfunction returned to previous rates).
In the Automode®-Group no malfunctions or cases of apnea were observed.
Increased rates of grade 3/4 adverse events specifically related to fluoropyrimidines (predominantly neutropenia) were observed in patients who experienced a pump malfunction.
Some of these malformations were observed in our cases and correspond to malfunction of ectodermal placodes – rudimentary limbs, thoracoabdominoschisis, internal organ malformations.
The observed groundwater pressure before the eruption also shows spikes caused by the malfunctioning sensor, but, fortunately, just a few hours before the eruption, normal values were observed.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com